drug law

US Food and Drug Administration’s Requirements on Content and Format for Labeling for Human Prescription Drugs Rule (1979)

US Food and Drug Administration’s Requirements on Content and Format for Labeling for Human Prescription Drugs Rule (1979)

The Food and Drug Administration’s Content and Format for Labeling for Human Prescription Drugs Rule, or the 1979 Labeling Rule, first assessed the risk of prescription drugs in pregnant women and fetuses. Prior to 1979, drug labels were only required to state true information, but there were no requirements for content or format.

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